A Phase I Study, Evaluating the Safety, Pharmacokinetics and Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors

Sponsor

Zhuhai Yufan Biotechnologies Co., Ltd (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05159700

Collaborator

(none)

Enrollment

Locations

Arm

28.5

Anticipated Duration (Months)

9.2

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This is a Phase I, multicenter, open-label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024 in subjects with relapsed/refractory solid tumors.

Condition or Disease	Intervention/Treatment	Phase
Advanced Solid Tumor Advanced Solid Malignancies	Drug: PRJ1-3024	Phase 1

Detailed Description

The study will evaluate the safety, tolerability, PK, and pharmacodynamics of PRJ1-3024 and will determine the maximum tolerated dose in subjects with advanced solid tumors.

PRJ1-3024 will be evaluated as an oral therapeutic that tests the anti-tumor activity of PRJ1-3024 in patients with solid tumors and has not yet been tested in humans.

This study will find the safe and tolerable recommended dose in subjects with advanced solid tumors as a open-label, 3+3 dose escalation study.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

46 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

This is a Phase 1, open label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024.This is a Phase 1, open label, 3+3 dose escalation study to determine the safety and preliminary efficacy of PRJ1-3024.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Phase I, First-In-Human, Open-Label Study Evaluating the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of PRJ1-3024 in Subjects With Advanced Solid Tumors

Actual Study Start Date :

Mar 31, 2022

Anticipated Primary Completion Date :

Feb 15, 2024

Anticipated Study Completion Date :

Aug 15, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Monotherapy Escalation 3+3 Dose escalation arm with PRJ1-3024 which will begin with 2 subjects treated at the lowest planned dose level PRJ1-3024 is administered orally once daily. The starting dose is 80mg/day.	Drug: PRJ1-3024 PRJ1-3024 is provided as capsules and is administered orally once a day.

Arm

Intervention/Treatment

Experimental: Monotherapy Escalation

3+3 Dose escalation arm with PRJ1-3024 which will begin with 2 subjects treated at the lowest planned dose level PRJ1-3024 is administered orally once daily. The starting dose is 80mg/day.

Drug: PRJ1-3024

PRJ1-3024 is provided as capsules and is administered orally once a day.

Outcome Measures

Primary Outcome Measures

Incidence of dose-limiting toxicity (DLT) events during the DLT monitoring period [Day 1 to Day 21]
Safety listings and pharmacokinetic listings will be used for evaluation

Secondary Outcome Measures

Incidence of adverse events (AEs) [24 months]
Characterized by type, seriousness, relationship to study treatment, timing, and severity.
Pharmacokinetic parameter： Accumulation ratio [24 months]
to estimate the accumulation of PRJ1-3024 from time 0 to the time of last quantifiable concentration after multiple administration
Objective response rate (ORR) [24 months]
estimated by the proportion of subjects having a complete response (CR) or partial response (PR) with use of RECIST v1.1 criteria.
Duration of response (DOR) [24 months]
defined as time from the first occurrence of a documented objective response to the time of relapse or death from any cause.
Pharmacokinetic parameter：AUC（0-last） [24 months]
Area under the concentration-time curve AUC from time 0 to the time of the last quantifiable concentration
Pharmacokinetic parameter：Maximum observed concentration (Cmax) [24 months]
assessed as time from time 0 to the time of the last quantifiable concentration

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Key Inclusion Criteria:

Histologically or cytologically confirmed locally advanced (unresectable) or metastatic r/r solid tumors for which no standard therapy is available or for whom standard therapy is considered unsuitable or intolerable.
Male or non-pregnant, non-lactating female subjects age ≥18 years.
ECOG Performance Status 0~2.
Has at least 1 measurable lesion as defined by RECIST 1.1 criteria .
Life expectancy of >3 months, in the opinion of the Investigator.
Able to take oral medications and willing to record daily adherence to investigational product.
Adequate hematologic parameters unless clearly due to the disease under study.
Adequate renal and hepatic function
Able to understand and willing to sign a written informed consent form.

Key Exclusion Criteria:

History of another malignancy
Known symptomatic brain metastases requiring >10 mg/day of prednisolone.
Significant cardiovascular disease
Known active HBV, HCV, AIDS-related illness.
Has received a live vaccine within 30 days
History of active autoimmune disorders or ongoing immunosuppressive therapy.
Receiving concurrent anti-cancer therapy, investigational product, strong inhibitors or inducers of cytochrome P450 3A (CYP3A) .
Prior treatment with hematopoietic progenitor kinase 1 (HPK1) inhibitors.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sarah Cannon Research Institute at HealthONE	Denver	Colorado	United States	80218
2	Sarah Cannon Research Institute at Florida Cancer Specialists	Orlando	Florida	United States	32827
3	Christ Hospital	Cincinnati	Ohio	United States	21073
4	NEXT Oncology	Austin	Texas	United States	73301
5	NEXT Oncology	Fairfax	Virginia	United States	22031